Satiety, Meal Frequency and Nutritional Aspects (SAFRAN)

Behavioural and Metabolic Consequences of Increasing Eating Frequency

In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :

• the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
• eating behavior during an ad libitum buffet test meal

Study Overview

• Status: Terminated
• Conditions: Volunteers
• Intervention / Treatment: Other: Increasing eating frequency

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre Bénite, France, 69495
    • Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• No smokers
• BMI 20 to 35 kg/m2
• Moderate physical activity
• Safety during medical consultation
• Feeding behavioural phenotype (Dutch Eating Questionnaire, Three Eating Factor Questionnaire)

Exclusion Criteria:

• Medical history which may affect glucose metabolism (diabetes, renal or hepatic failure, thyroid dysfunction, Cushing syndrome, acromegaly…)
• Medical history which affect nutrient absorption (gastro-intestinal and pancreatic disease, gastrectomy, colectomy…)
• Drug use in the last two months that could affect glucose metabolism (steroids, topical gastric preparation, anorectic drugs…)
• Eating disorders
• Claustrophobic subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: non-obese volunteers; Volunteers with a BMI (Body Mass Index) between 20 and 25 kg/m2.	Other: Increasing eating frequency; The subjects receive the same breakfast with two sequences : breakfast in one intake at 8:00; breakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior The lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal. The administration order is determined by randomized allocation. The wash-out period is one to three weeks. There are not diet or exercise interventions.
Other: Obese volunteers; Volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2.	Other: Increasing eating frequency; The subjects receive the same breakfast with two sequences : breakfast in one intake at 8:00; breakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior The lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal. The administration order is determined by randomized allocation. The wash-out period is one to three weeks. There are not diet or exercise interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ghrelin plasmatic concentration	240 minutes after breakfast beginning (just before the lunch)

Secondary Outcome Measures

Outcome Measure	Time Frame
Satiety through food intakes (quantitative) at the ad libitum buffet test meal	Since the beginning of the buffet test meal (240 minutes after breakfast beginning) to the end of the meal (at the latest 270 minutes after breakfast beginning).
Satiety through visual analogue scale	240 minutes after breakfast beginning (just before the lunch)
Plasma metabolite concentrations (glycaemia, non esterified fatty acid,	kinetics during 430 minutes
Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide)	kinetics during 430 minutes
Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide)	kinetics during 430 minutes
Lipid oxidation	kinetics during 430 minutes
Eating behaviour at the buffet test meal by video recording (food choice, nutritional composition of the meal , kinetics of nutrient intake, meal structure, lunch duration)	during the buffet test meal (max : 30 minutes)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Nutrition; Satiety; Food intake; Ghrelin; Eating behavior; Eating frequency
• Other Study ID Numbers: 2010.612/16